Overview

Transdermal Estrogen in Women With Anorexia Nervosa

Status:
Recruiting
Trial end date:
2024-08-30
Target enrollment:
0
Participant gender:
Female
Summary
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Pouneh K. Fazeli, MD
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Estrogens
Criteria
Inclusion Criteria:

1. Female

2. 20-45 years of age

3. DSM-5 psychiatric criteria for anorexia nervosa

4. <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height
and Weight Tables

5. Amenorrhea

6. T-score of < -1.0 at spine or hip

Exclusion Criteria:

1. Diseases known to affect bone metabolism, including untreated thyroid dysfunction,
vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency
(eGFR < 60)

2. Personal history of venous or arterial clot

3. History of stroke or myocardial infarction

4. History of migraine headaches

5. History of hypercoagulable disorder

6. Personal history or history of a first-degree relative with breast cancer

7. History of hereditary angioedema

8. Any medication known to affect bone metabolism, including systemic glucocorticoids
within three months of the baseline visit, depot medroxyprogesterone within 6 months
of the baseline visit, oral bisphosphonates within one year of the baseline visit or
IV bisphosphonates within three years of the baseline visit

9. Bone fracture within the prior 12 months

10. Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or
Hemoglobin < 10 g/dL

11. Fasting serum triglyceride level > 150 mg/dL

12. Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)

13. Active substance abuse

14. Elevated PTH level

15. 25-OH vitamin D level < 20 ng/mL

16. Low phosphorus level